![]() The use of data removed of patient identifiers is one of three current options available to investigators desiring to use medical data in research, besides obtaining informed consent from their patients or a waiver of informed consent from their institutional review board (IRB). The Common Rule sets the basic principles for protecting patients from research risks, using human tissues in support of medical research, and guiding the activities of Institutional Review Boards. There are 18 “safe harbor” data identifiers under the Privacy Rule that constitute the minimal set of removed identifiers. The Privacy Rule permits covered entities (i.e., health plans, health care clearinghouses, or health care providers who transmit health information in electronic form in connection with a transaction for which HHS has adopted standards) to use and disclose data that have been removed of patient identifiers without obtaining an authorization and without further restrictions on use or disclosure because data removed of these identifiers are no longer protected health information (PHI) and, therefore, are not subject to the Privacy Rule. In response to a congressional mandate in the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Department of Health and Human Services (HHS) issued the HIPAA Privacy Rule regulations in December 2000. is covered under the Standards for Privacy of Individually Identifiable Health Information (usually referred to as the Privacy Rule), and The Common Rule. ![]() The use of medical records and human tissues in biomedical research in the U.S.
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